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NCT06258590 · ClinicalTrials.gov registry record · NA

taVNS for Anxiety in ASD

A NA study of Anxiety and Autism Spectrum Disorder, sponsored by Medical University of South Carolina.

Recruiting
Registry status
NA
Development phase
10
Enrollment target
1
Study location

NCT06258590 is a NA study of Anxiety and Autism Spectrum Disorder that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 10 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06258590, a NA study of Anxiety and Autism Spectrum Disorder, is actively recruiting participants, sponsored by Medical University of South Carolina.

RECRUITING
Registry status
NA
Development phase
10 participants
Enrollment target
1
Study location

Study Summary

Investigators will recruit up to 10 patients with Anxiety comorbid with Autism Spectrum Disorder (ASD) from the outpatient clinics at MUSC. This pilot trial will be an open-label investigation of the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) as a nonpharmacological wearable intervention used to manage anxiety and other neuropsychiatric symptoms at home, with patients/caretakers self-administering treatments. Each subject will undergo an initial in-person screening and be consented prior to participating in the study. This will be followed by an in-person training session with the subject (and caretaker if applicable), where they will learn how to self-administer taVNS and ask any pertinent questions. Participants will self-administer taVNS at home twice daily for 4 weeks. These treatments will not interfere with other aspects of their mental health care. Our investigators, over the prior 8 years, have demonstrated that taVNS is safe and feasible in the outpatient setting. Furthermore, investigators have recently demonstrated that taVNS is well tolerated and safely self-administered at home with remote monitoring. The investigators hypothesize that taVNS will be safe and feasible to administer at home in this new population. Results from this study may lead to further exploration of taVNS in this unique population.

Interventions

  • DEVICE Transcutaneous auricular vagus nerve stimulation

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2024-04-04
Est. Completion 2026-02-24
Phase NA

What the Registry Record Tells You About NCT06258590

The ClinicalTrials.gov registry entry for NCT06258590 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (98% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 1 intervention - of which Transcutaneous auricular vagus nerve stimulation is the first listed.

NCT06258590 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.

Frequently Asked Questions

What is clinical trial NCT06258590 about?

NCT06258590 is a clinical study titled "taVNS for Anxiety in ASD". Investigators will recruit up to 10 patients with Anxiety comorbid with Autism Spectrum Disorder (ASD) from the outpatient clinics at MUSC. This pilot trial will be an open-label investigation of the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) as a nonpharmacol...

What is the current status of trial NCT06258590?

This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2024-04-04. Estimated completion is 2026-02-24.

What conditions does trial NCT06258590 study?

This clinical trial studies the following conditions: Anxiety, Autism Spectrum Disorder.

What interventions are being tested in trial NCT06258590?

The interventions under investigation include: Transcutaneous auricular vagus nerve stimulation (DEVICE).

Who is sponsoring clinical trial NCT06258590?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06258590 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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